Mr. Riggs:Advanced
Cancer Therapeutics was brought into existence to leverage existing and new
breakthrough therapies in cancer that are discovered at the James Graham
Brown Cancer Center (“Brown Cancer Center”). We then take those early-stage
drugs/molecules under pre-set licensing terms that allows us to move quickly
to make the drugs better and increase the strength of the patent position
around those new molecules. Then we move those improved drugs into Phase I
human clinical trials for the benefit of cancer patients. After Phase I
trial, we then look to license or sell the asset to leading pharmaceutical
companies that have more bandwidth and financial resources to do late-stage
development and commercialization. Once we license the anti-cancer product
to a third party, we continue to have a stake in the product(s) moving
forward in terms of up-front license fees, clinical milestone payments and
royalties on products sales. We use a lot of that money not only to pay back
our investors, but also to bring back money to the Brown Cancer Center so
that they can continue developing these much-needed breakthrough cancer
therapies.

CEOCFO: Do
you pick and choose, or do you take all the ideas and attempt to work with
them?

Mr. Riggs:We do choose.
We select, and what we are looking for are things that have the potential to
be breakthrough or transformational and have exhibited some in vivo animal
efficacy studies. We can then take the compound or molecule and do what we
call SAR, which is structure activity relationship or termed as medicinal
chemistry. We make the compounds with better drug-like attributes for use in
humans. In addition, you also perform SAR activities to improve the
intellectual property strength of the asset. In our industry, intellectual
property is a critical component because it costs so much to develop a drug.
You have to have a very strong patent position to have exclusivity to
develop and commercialize the therapeutic and provide an appropriate return
on investment.

CEOCFO: At
what point might the researcher say it is time to talk to you, or are you
supervising the research and deciding when to get involved?

Mr. Riggs:We do
interact a lot with all the 80+ research scientists at the Brown Cancer
Center. We are aligned with them not only from a partnership standpoint but
also from an economical standpoint. They own a little over 30% of ACT, so
when we do well, they do well. We have structured our business strategy this
way because we are fitting into this niche when researchers make a discovery
most of the time the stage of the asset is very early in the drug
development process and the researcher needs someone else to take it through
the valley of death. The valley of death as we refer to it in the
pharmaceutical industry, are those promising early stage discoveries that
have not yet entered human clinical trials. That is where ACT enters into
the process. If the asset demonstrates good activity/efficacy in animals and
the compound looks promising, we can license it from them and we will pay
them an up-front license fee and clinical milestone payments and royalties
on product sales. We can make the asset much more valuable by taking it
through the pre-clinical research stage and advance it into humans where we
see safety and clinical activity of the drug. At that point, the asset is
very valuable because the pharmaceutical company understands that value
proposition. It is a unique asset that addresses a specific disease, for
example, for the treatment of breast, lung or prostate cancer. When we
license or sell the asset, a lot of those proceeds will return to the Brown
Cancer Center and benefit the inventors who initially discovered the
product, as well as provide funds for the next potential breakthrough
product.

CEOCFO:
When you are looking at what projects to take on, are you looking for a
particular mix or is each potential drug or discovery vetted on its own?

Mr. Riggs:What I am
looking for is a product that will address an unmet medical need in cancer
that could have a big impact on cancer patients’ lives. For example, the
first product we have advanced into Phase I human trials is a key cancer
target that when you inhibit it, it prevents the tumor cells from using
glucose as a fuel source to survive, grow and metastasize. This target
mostly drives solid tumors like breast, lung, prostate and colon cancers.
Inhibition of this target, called PFKFB3, prevents those tumors from using
glucose as a key fuel source to grow and metastasize. Our drug, PFK-158, in
Phase I human clinical trials, prevents many solid tumors from being able to
use glucose as a key energy source to grow and wreak havoc on the human
body. This is really a wonderful product, and if you think about some of our
best products in cancer even today, one can see that in a drug like Avastin®,
which makes over six billion in annual revenues and treats an assortment of
solid tumors. Avastin® prevents tumors from gaining access to blood as a
nutrient for survival, growth and metastasis. With PFK-158, ACT is using a
similar strategy against tumors cells by preventing tumors from gaining
access to glucose as a key energy source used by tumors to survive, grow and
metastasize.

CEOCFO:
Why does the glucose work?

Mr. Riggs:This target
is highly expressed in tumor cells, not in healthy cells, so it will be
selective for a variety of solid and hematological tumors. Tumors have an
inefficient nucleus and an insatiable desire to quickly multiply or
proliferate. That is how cancer ends up wreaking havoc on cancer patients
and can lead to a patient’s death. Tumors use glucose as a key fuel source
to survive, grow and metastasize. This concept is well known within the
pharmaceutical industry. In fact, back in the early 1930s, a German doctor
named Dr. Warburg. Dr. Warburg professed that many cancers have an
insatiable demand for glucose uptake as a key fuel source for survival and
growth. While this idea for treating a variety of cancers has been around
for some time, not much work in this area has been accomplished with the
exception of our first-in-man, first-in-class glucose inhibitor, PFK-158. We
are the first company to enter into human clinical trials to address this
unique cancer target with the novel drug, PFK-158, that inhibits glucose
uptake in tumor cells. CEOCFO: Has the medical community been paying
attention or is it too early?

Mr. Riggs:I think they
have been paying attention. We are in discussions with several leading
pharmaceutical companies, and just last week I presented PFK-158 in Boston,
Massachusetts at TAP, which is the Therapeutic Area Partnerships. TAP is
sponsored by Informa and Kantar Health. We were one of the Top Ten Oncology
Drugs to watch in 2014 and PFK-158 was selected by an independent panel of
oncology experts. I believe we are being noticed, and I think this is
important because we make significant breakthroughs when we try to attack
cancer from a novel mechanism perspective. It is very difficult to make
those types leaps or breakthroughs when you do follow-on or copycat
products. We seek novel mechanisms that not only would have a profound
impact on the cancer as a stand-alone treatment, but also in combination
with currently available cytotoxic and targeted anti-cancer therapies. For
example, we have demonstrated that PFK-158 has synergistic activity with
Cisplatin in animal studies with resistant ovarian cancer. Cisplatin is a
common drug used for treating ovarian cancer patients. Treating difficult
cancers with a combination of drugs is the way most oncologists treat cancer
patients today. Oncologists use a combination of products that hit the
cancer at multiple areas of critical importance with the goal to stop or
delay disease progression.

CEOCFO:
Where does gut feeling come in along with the science?

Mr. Riggs:I believe in
our industry the people who have been successful must have a mixture of gut
instinct, passion and perseverance. I evaluate the asset from an objective
standpoint but also from a gut instinct. However, at the end of the day you
have to have passion and perseverance in this challenging industry that has
many ups and downs. You will have obstacles thrown at you that you cannot
imagine, and they will really put you on your knees, but if you have that
core passion for your product, you can call upon that to help you persevere
during the down times and continue moving forward.

CEOCFO:
What is next on the agenda?

Mr. Riggs:We are
looking to complete the Phase I human clinical trial in the first half of
2015. Currently, we have two clinical sites: the University of Louisville
Hospital, Georgetown Medical in Washington D.C. Recently, we signed on M.D.
Anderson in Houston, Texas, which is one of the best cancer centers in the
world, and the University of Texas Medical Center in San Antonio, Texas,
which is also a very respected oncology center. I believe engaging all four
of these reputable medical centers with our Phase I trial speaks volumes to
the asset quality of the PFK-158 program. We intend to complete treating
patients in our Phase I trial, then we will look to partner or sell PFK-158
to a leading pharmaceutical company to generate revenue that will be used to
develop the next potential breakthrough treatment. We plan to keep repeating
this process again and again. The Brown Cancer Center has 80+ researchers
ACT can leverage upon that are focused on discovering breakthrough
treatments for oncology. While they own a little over 30 percent of ACT, ACT
does not pay their salaries, facilities, equipment, employee benefits, etc.,
which allows ACT to remain productive and lean. If I were a conventional
biotech company, my annual expenses would be much greater than it is under
ACT’s current business structure. We have been operating like this since
2007 and it works very well for both ACT and the Brown Cancer Center, and we
believe it will continue to work well for many years to come.

CEOCFO:
There are many companies in your industry for people to look at. Put it
together. Why Advanced Cancer Therapeutics?

Mr. Riggs:I believe
people should be paying attention today because of our close and symbiotic
relationship with the Brown Cancer Center that focuses on leading edge
discoveries in oncology. Historically, if you look where most of the really
big discoveries originated, it has been from academic and medical
institutions. In fact, many pharmaceutical companies are reducing their
early-stage drug discovery activities because they continue to see declining
productivity in innovation within their organizations. Innovation appears to
be more prolific within small biotech or academic institutions. At ACT, we
combine the best of both worlds – the commercial biotech company, ACT, which
has very experienced people with over 20 years of experience doing
early-stage discovery / development working with leading medical
institutions like the Brown Cancer Center to capitalize on those
breakthrough treatments. You never know where the next breakthrough
treatment will come from, but we have our hands on the pulse very closely. I
should also note that while we have a close relationship with the Brown
Cancer Center, we are not only exclusive to the Brown Cancer Center. We have
several other institutions approaching us with new discoveries for
evaluation because of what we have been able to accomplish with the Brown
Cancer Center. Therefore, we not only get the best opportunities from the
Brown Cancer Center, we are also fortunate to evaluate new potential
breakthrough products from other institutions. I believe some of these
institutions approach us because they may see us as an attractive path
forward to advance their early discoveries through the valley of death that
may lead to a better asset value proposition for pharmaceutical companies.

“We seek novel mechanisms that not only would
have a profound impact on the cancer as a stand-alone treatment, but also in
combination with currently available cytotoxic and targeted anti-cancer
therapies.” - Randall B. Riggs

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Therapeutics, Healthcare Companies, CEO Interviews 2014, Randall B. Riggs,
Discovery and Early Development of Novel Cancer Therapeutics, first-in-man,
first-in-class glucose inhibitor, PFK-158, in Phase I human trials for a key
cancer target PFKFB3, that when you inhibit it, it prevents the tumor cells
from using glucose as a fuel source to survive, grow and metastasize, PFKFB3
mostly drives solid tumors like breast, lung, prostate and colon cancers,
sugar and cancer, Recent CEO Interviews, cancer therapies discovered at the
James Graham Brown Cancer Center (“Brown Cancer Center”), tumors use glucose
as a key fuel source to survive, grow and metastasize, this concept is well
known within the pharmaceutical industry, Inhibition of this target, called
PFKFB3, prevents those tumors from using glucose as a key fuel source to
grow and metastasize, our drug, PFK-158, in Phase I human clinical trials,
prevents many solid tumors from being able to use glucose as a key energy
source to grow and wreak havoc on the human body, tumors have an inefficient
nucleus and an insatiable desire to quickly multiply or proliferate, which
is how cancer ends up wreaking havoc on cancer patients and can lead to a
patient’s death, in the early 1930s Dr. Warburg professed that many cancers
have an insatiable demand for glucose uptake as a key fuel source for
survival and growth, our. We are the first company to enter into human
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